Model Number 518-062 |
Device Problems
Device Operates Differently Than Expected (2913); Human Factors Issue (2948); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Excessive Tear Production (2235); Foreign Body In Patient (2687)
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Event Date 10/28/2016 |
Event Type
Injury
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Event Description
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This (b)(6) yo female presented for extraction of a dual-coil mdt sprint fidelis (6949) lead.The lead was prepared for extraction by attempting to retract the helix, this was unsuccessful.A spectranetics lead locking device was inserted into the mdt (6949) lead.A 14fr.Glidelight was used for the procedure.The patient experienced hemodynamic changes when the laser reached the ra.A spectranetics bridge balloon was placed on the back table and threaded up the femoral wire that was placed pre-operatively.Once advanced into the svc, the bridge guidewire was inadvertently removed, which may cause instability of the balloon.The balloon was inflated and under fluoroscopy, conformed to the svc, however patient status remained unchanged.Cpr was begun as the cardiac surgeon arrived.The injury was described as a tear of the svc.During the intervention, the mdt 6949 lead was cut and remains in the patient.The patient did not survive the procedure.This report is made against the lld being left within the patient.A report will be made on the glidelight in this case; 1721279-2016-00172.
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Manufacturer Narrative
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Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.
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Manufacturer Narrative
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B1): corrected to adverse event and problem b2): outcomes now reflected as "other" since lld was cut and capped, instead of "death" (captured in the initial mdr).G3): manufacturer became aware of the need for supplemental correction mdr on 03 aug 2021.H1): type of reportable event corrected to "serious injury".H3): the device was discarded, thus no investigation could be completed.H6): archived device code 2887 corrected to 2993.Archived patient code 2513 remains applicable for this event.Postmarket surveillance performed a record review and discovered that three mdr''s (1721279-2016-00171, 1721279-2016-00172 and 1721279-2016-00173) were submitted for "death" for the same patient.This duplicated the patient''s death, which trended more deaths than actually occurred.This supplemental mdr is being submitted to change "death" to "injury", accurately reflecting the event and avoiding "death" duplication.Mdr #1721279-2016-00172 will remain unchanged.
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Search Alerts/Recalls
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